The Recall Desk

Hazard

Gmp Violation recalls

823 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
823
Critical
49
Severe
377
Most recent
2026-03-04

Of the 823 gmp violation recalls we have scored against our rubric, 49 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 377 (46%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all gmp violation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

76–100 of 823

  • SevereFDA (Drugs)·D-1638-2015·2015-09-23

    FDA Recalls Sufentanil and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Sufentanil and Bupivacaine solution because FDA inspections found violations that may have compromised sterility.

    Product
    Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1490-2015·2015-09-23

    FDA Recalls Compounded Fentanyl and Bupivacaine Intrathecal Solution for Sterility Concerns

    The Compounding Pharmacy of America is recalling specific lots of compounded intrathecal solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1445-2015·2015-09-23

    Baclofen Intrathecal Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Baclofen 1,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1599-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 40 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1682-2015·2015-09-23

    FDA Recalls Intrathecal Solution Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling a specific intrathecal solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1769-2015·2015-09-23

    Tri-Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Tri-Mix injectable products due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Tri-Mix (20/1/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1751-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 87.5 mg Sterile Pellets because FDA inspections identified GMP violations that may impact sterility.

    Product
    Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1676-2015·2015-09-23

    FDA Recalls Compounded Hydromorphone Fentanyl Bupivacaine Intrathecal Solution

    The Compounding Pharmacy of America is recalling compounded intrathecal solution due to FDA inspection findings of GMP violations that impact sterility assurance.

    Product
    Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1789-2015·2015-09-23

    Tri-Mix Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix AT-6 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1435-2015·2015-09-23

    Acetylcysteine Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Acetylcysteine 100 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1648-2015·2015-09-23

    Testosterone Injection Recalled for Potential Sterility Issues

    The Compounding Pharmacy of America is recalling Testosterone USP Aqueous 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1613-2015·2015-09-23

    Morphine and Bupivacaine Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution due to FDA inspection findings regarding sterility assurance.

    Product
    Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1757-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1678-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Pain Medication Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a compounded intrathecal pain medication because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1798-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST9A injectable products due to FDA inspection findings of GMP violations that may affect sterility.

    Product
    Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1588-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 20 mg/ml Solution because FDA inspections found GMP violations that may impact sterility.

    Product
    Morphine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1640-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 100 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1477-2015·2015-09-23

    Estradiol Cypionate Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol Cypionate 5mg/ml injectable vials because FDA inspections identified GMP violations that may impact product sterility.

    Product
    Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1436-2015·2015-09-23

    Alprostadil Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Alprostadil 10 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1498-2015·2015-09-23

    Fentanyl and Clonidine Intrathecal Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Clonidine intrathecal solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 5,000 mcg/ml + Clonidine 3,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1451-2015·2015-09-23

    Cholecalciferol Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Cholecalciferol 100,000 IU/ml Injectable due to GMP violations that may impact sterility.

    Product
    Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1474-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 50 mg sterile pellets because FDA inspections found GMP violations that may impact sterility.

    Product
    Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1631-2015·2015-09-23

    Sermorelin/GHRP6 Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sermorelin/GHRP6 Injection due to FDA inspection findings of GMP violations that impact sterility assurance.

    Product
    Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1503-2015·2015-09-23

    Glutathione Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Glutathione 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1555-2015·2015-09-23

    Hydromorphone Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 70 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

    Product
    Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide